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Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01419873
First Posted: August 18, 2011
Last Update Posted: August 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Adrienne Lynn, Christchurch Women's Hospital
  Purpose

Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems.

There are a range of ways to manage high sugar levels but there are no consensus guidelines to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia.

This study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.


Condition Intervention Phase
Hyperglycaemia Drug: Actrapid Human Insulin Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

Resource links provided by NLM:


Further study details as provided by Adrienne Lynn, Christchurch Women's Hospital:

Primary Outcome Measures:
  • Hypoglycaemia whilst receiving insulin [ Time Frame: Length of hospital stay in NICU which will be from birth to 5 months of age ]
    Hypoglycaemia whilst the patient is receiving insulin as per the model-based method will be documented. The patients may require insulin at any time in their admission to NICU from birth to a maximum of 5 months of age when they would no longer be admitted to NICU.


Enrollment: 30
Study Start Date: August 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Actrapid Human Insulin
    Actrapid Insulin is a drug used in routine neonatal practice to treat hyperglycaemia. The intervention in this study was to base dosing on insulin by a computer based-model approach as opposed to sliding scales, fixed protocols or clinician intuition
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Birthweight <1500g
  • Blood sugar >/= 10mmol/L
  • Clinician decision to start an insulin infusion

Exclusion Criteria:

  • Infants who were moribund and not expected to survive
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419873


Locations
New Zealand
Christchurch Womens Hospital, Canterbury District Health Board
Christchurch, New Zealand
Sponsors and Collaborators
Christchurch Women's Hospital
Investigators
Principal Investigator: Adrienne M Lynn, FRACP Canterbury District Helath Board
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adrienne Lynn, Dr Adrienne Lynn, Christchurch Women's Hospital
ClinicalTrials.gov Identifier: NCT01419873     History of Changes
Other Study ID Numbers: URA/08/06/039
First Submitted: August 12, 2011
First Posted: August 18, 2011
Last Update Posted: August 29, 2011
Last Verified: August 2011

Keywords provided by Adrienne Lynn, Christchurch Women's Hospital:
Hyperglycaemia
Very low birthweight infants
Insulin

Additional relevant MeSH terms:
Hyperglycemia
Birth Weight
Glucose Metabolism Disorders
Metabolic Diseases
Body Weight
Signs and Symptoms
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs